Dengue NS1 Rapid Test Kit
(Colloidal Gold)
【Product Name】
Generic name: Dengue NS1 Rapid Test Kit
(Colloidal Gold)
【Packing Specification】
25 tests/box
【Intended
Use】
This kit is applicable for in
vitro qualitative test of Dengue NS1 antigen in the sample of human serum.
Clinically, this kit is mainly
applicable for auxiliary diagnosis of dengue fever.
【Test
Principle】
By the immunochromatographic
technique, this kit tests the Dengue NS1 antigen through double antibody
sandwich method. At the test, the treated extract is dripped into sample
injection hole of test card. When Dengue NS1 antigen exists in test sample and
its concentration is higher than minimum detection limit, Dengue NS1 antigen
first forms with labeling antibody into reaction complex. Under the
chromatographic action, the reaction complex moves forwards along
nitrocellulose membrane; it is separately captured by Dengue NS1 monoclonal
antibody precoated in test area on the nitrocellulose membrane. In the test
area, one red/pink reaction line is finally formed; at this time, a positive
result is indicated. On the contrary, when Dengue NS1 antigen does not exist in
test sample or its concentration is lower than minimum detection limit, the
red/pink reaction line will not appear in test area; at this time, a negative
result is indicated. No matter whether Dengue NS1 antigen exists in test
sample, one red/pink reaction line will be formed in quality control area (C).
The red/pink reaction line displayed in quality control area (C) is the judgment
criteria for whether the chromatographic course is normal, and also the
internal control standard for kit.
【Main
Component】
|
Ingredients
|
Quantity/Specification
|
Main components:
|
|
Test card (with desiccant)
|
1 test/bag
|
Each test card is mainly
composed of plastic casing and test strip. As main component of test strip,
the nitrocellulose membrane is coated with Dengue NS1 monoclonal antibody and
anti-rabbit IgG antibody. Binding pad is coated with colloidal gold labeled
Dengue NS1 monoclonal antibody and goat anti-rabbit IgG antibody. Other
components include: polyester membrane and water absorbent paper.
|
|
Sample diluent
|
25 pieces/box
|
Mainly phosphate buffer solution (PBS) (0.1 M, pH7.2±0.2).
|
centrifugeStorage
Conditions and Validity】
This kit is kept at 2~30℃, under sealed state of
aluminum foil bag. Its shelf life is 18 months. After the unsealing of aluminum
foil bag, this kit should be used within one hour. Production date and expiry date are shown in
the package or label.
【Sample Requirements】
1.
Whole
blood is collected through conventional method. The hemolytic sample can not be
used. All samples should be treated as infection factor.
2.
For
the plasma sample, only anticoagulants of EDTA, heparin and sodium citrate can
be used; other anticoagulants do not pass the test.
3.
The
sample of serum or plasma should be kept under room temperature (18~26℃) for
not more than one day, at 2~8℃ for not more than three days, and at -20℃ for
not more than one month.
4.
Before
the test, the sample must be restored to room temperature. Only after the
complete thawing, temperature restoration and uniform mixing, the sample of
frozen storage can be used.
【Test Method】
1.
Only
after the restoration to room temperature (20~25℃), the kit of low-temperature
storage can be used.
2.
External
package is torn off. Test card is taken out, and put flatly onto the surface of
horizontal operating table.
3.
Serum
sample is drawn through sucker. It is dripped vertically into sample injection
hole first by 1 drop (about 30~45 uL), and then by another 1 drop (about 30~45
uL) for dilution.
4.
After
15~20 minutes, display result is observed. The display result after 30 minutes
becomes insignificant.
【Interpretation of Test Results】
|
Negative/Positive
|
Results
display
|
|
Positive (Dengue NS1 antigen exists in test
sample and its concentration is equal to or higher than minimum detection
limit)
|
Both
quality control line and test line turn red.
|
|
Negative (Dengue NS1 antigen does not exist in
test sample or its concentration is lower than minimum detection limit)
|
Quality
control line turns red; but test line is not colored.
|
|
Insignificant
|
Both
quality control line and test line are not colored.
|
【Limitations of Test Method】
1.
This
kit is used only for auxiliary diagnosis. Final clinical conclusion should be
made through doctors by overall considering other diagnostic/examination
results and test data.
2.
Possible
reasons for false positive result: Similar antibody or antigen of high
concentration in the sample produces cross reaction. Some small molecular
substances with similar antigenic determinant to that of NS1 antigen produce a
nonspecific binding with colloidal gold labeled antibody.
3.
Possible
reasons for false negative result: The concentration of test substance is
extremely high in the sample to produce HOOK effect; under the extreme
condition, false negative result will be displayed. Some unknown compositions
shield the antigenic determinant from binding with antibody.
4.
Wrong
results may also be caused by other factors, including: technological factors,
misoperation and other sample factors.
【References】
[1]
Halstead SB, Russell PK, Brandt WE. NS1,
Dengue's Dagger. J Infect Dis. 2020 Mar 2;221(6):857-860.
[2]
Halstead S. Recent advances in understanding
dengue. F1000Res. 2019 Jul 31;8:F1000 Faculty Rev-1279.
[3]
Muller DA, Depelsenaire AC, Young PR. Clinical
and Laboratory Diagnosis of Dengue Virus Infection. J Infect Dis. 2017 Mar
1;215(suppl_2):S89-S95.
【Basic Information】
Name of enterprise: Shenzhen Lvshiyuan
Biotechnology Co., Ltd.
Registered address: Room 101, 201 and 301,
Building D, National Biological Industrial Park of Marinelife, No.2 Binhai
Road, Dapeng, Shenzhen, China.
Production address: Room 101, 201 and 301,
Building D, National Biological Industrial Park of Marinelife, No.2 Binhai
Road, Dapeng, Shenzhen, China.
Unit of after-sale service: Shenzhen Lvshiyuan
Biotechnology Co., Ltd.
Production License No:
YueSiYaoJianXieShengChanXu No.20142513
Zip code: 518120
Tel: 086-755-28438788/28438000
Fax: 086-755-28938800
Email: info@lsybt.com
Website: http://www.lsybt.com